Treatment of incompetent vessels

ABSTRACT

An implant device can include a frame and a cover member for delivery to and occlusion of a target body vessel. The frame can include proximal and distal members, coupled by a link member structure, and can expand from a collapsed configuration to an expanded configuration. In the collapsed configuration, a first plane passes through the proximal member and a second plane passes through the distal member, and the link member extends substantially parallel relative to a longitudinal axis of the device. In moving to the expanded configuration, the first and second planes each move angularly, relative to the longitudinal axis, from the collapsed configuration by between about 10 degrees and about 170 degrees, and the link member foreshortens along the longitudinal axis to bias the proximal member toward the distal member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the priority benefit of U.S. ProvisionalApplication No. 61/987,446, filed on May 1, 2014, the entirety of eachof which is incorporated herein by reference.

FIELD

The subject technology relates generally to apparatuses and methods forblood vessel occlusion and vascular stenting.

BACKGROUND

Veins can become incompetent through the weakening of blood vessel wallsor damage to or weakening of valves within the vein. Most frequently,veins carrying oxygen-depleted blood up the legs provide the mostapparent visual evidence of the vessel wall or valve weakening,demonstrating that a portion of the veins have become incompetent. Whenthe blood vessel walls weekend or the valves no longer serve theirfunction of reducing or preventing backflow of blood, the vain canbecome enlarged, weak, and twisted. This condition is referred to as avaricose vein.

While the causes of varicose veins are varied and common, varicose veinscan be treated using a variety of procedures.

SUMMARY

Treatment of varicose veins and other blood vessel problems can beachieved through some embodiments disclosed herein. Some embodimentsherein relate to vessel occlusion by delivery of radially expandableimplant frames that achieve immediate total occlusion of blood flow.Frame configurations, expected delivered and expanded dimensions, and adescription of target anatomy of some embodiments is provided.

Aspects of implants and delivery devices that can be utilized incombination with the implants, systems, methods, and features disclosedherein are disclosed in: U.S. patent application Ser. No. 12/826,593,filed on Jun. 29, 2010; U.S. patent application Ser. No. 13/367,338,filed on Feb. 6, 2012; U.S. Patent Pub. No. US20120095489, published onApr. 19, 2012; U.S. patent application Ser. No. 13/828,974, filed onMar. 14, 2013, U.S. patent application Ser. No. 14/044,794, filed onOct. 2, 2013; U.S. Patent App. No. 61/835,406, filed on Jun. 14, 2013;U.S. Patent App. No. 61/904,376, filed on Nov. 14, 2013; U.S. PatentApp. No. 61/904,379, filed on Nov. 14, 2013; U.S. Patent App. No.61/835,461, filed on Jun. 14, 2013; U.S. Patent App. No. 61/900,321,filed on Nov. 5, 2013; and U.S. patent application Ser. No. 14/101,171,filed on Dec. 9, 2013, the entireties of which are incorporated hereinby reference.

Additionally, some embodiments provided herein relate to implantation insmall blood vessels (veins or arteries), such as from about 3 mm toabout 20 mm, from about 5 mm to about 15 mm, or from about 7 mm to about11 mm. The target delivery profile can be from about 2 Fr to about 6 Fr,and in some embodiments, from about 3 Fr to about 5 Fr.

Further embodiments can provide vascular stenting for vessels that arefrom about 3 mm to about 16 mm, from about 5 mm to about 13 mm, and insome embodiments, from about 7 mm to about 11 mm. The target deliveryprofile can be from about 2 Fr to about 8 Fr, about 3 Fr to about 7 Fr,from about 4 Fr to about 6 Fr, or in some embodiments, about 5 Fr.Additionally, expansion of the implant can provide sufficient radialforce against the inside wall of a vein. Some embodiments can comprisefeatures or means configured to minimize backflow of blood or minimizevenous insufficiency. For example, treatment applications forembodiments of the device can include ilio-femoral venous obstructionand chronic iliac venous outflow obstruction as a result of venousdisease.

Further, some embodiments provided herein can be used to providetemporary or permanent occlusion of a vessel during and/or aftertreatment of a tumor by intravascular injection of fluids, chemotherapydrugs, liquid embolic agents, and/or other therapeutic agents deliveredinto the feeding vessels and/or into the tumor.

Some embodiments of the implants provided herein can be manufactured viaseveral methods including shape-setting of drawn wire, chemical etchingof a NiTi sheet of material, laser cutting of a tubular member, such asa material sheet or tubing, and/or electrical discharge machining (EDM)of a tubular member, such as a material sheet or tubing.

The implants disclosed herein can comprise flexible and/or shape memorymaterials such that they may be distorted from an expanded shape to asmaller diameter or straight shape to allow for delivery to a targetlocation by way of a minimally invasive catheter-based approach.

In accordance with some embodiments, the implant can comprise a frameand a cover material. The cover material can comprise ePTFE tubing,film, and/or suture for attachment purposes. Additionally, the covermaterial may be fibrous, mesh-like, or impermeable in density.

The implant frame and/or implant cover can comprise a collagen coatingor collagen treatment to improve anchoring of the implant in the targetvessel. The collagen can be configured to promote cell adhesion toimplant materials, thereby facilitating improved support for the implantand vessel structure while acting as an anti-migration feature for theimplant.

The implant frame can comprise a straight or constant diameter, atapering diameter, or sections of variable diameter extending over itslength, which can facilitate anchoring within a vessel and optimaldeployment function.

Some embodiments of the systems and devices disclosed herein address theunmet need for a device that can provide a fast, precise and reliableway to close a bodily lumen. The endoluminal occlusion system caninclude two major subsystems: a guide sheath assembly and an implantcarrier assembly. The implant carrier assembly can include an implantdevice and a handle assembly. Embodiments of the present disclosure canalso comprise various features disclosed in U.S. Pat. No. 8,328,840,issued on Dec. 11, 2012, the entirety of which is incorporated herein byreference.

The subject technology is illustrated, for example, according to variousaspects described below. Various examples of aspects of the subjecttechnology are described as numbered clauses (1, 2, 3, etc.) forconvenience. These are provided as examples and do not limit the subjecttechnology. It is noted that any of the dependent clauses may becombined in any combination, and placed into a respective independentclause, e.g., clause 1 or clause 55. The other clauses can be presentedin a similar manner.

Clause 1. An expandable device for delivery to a target location in abody vessel, comprising: a frame comprising proximal and distal membersand a link member having a first end coupled to the proximal member anda second end coupled to the distal member, the proximal and distalmembers being at opposite ends of a longitudinal axis; wherein the frameis expandable from (1) a collapsed configuration in which (i) a firstplane passes through the proximal member and a second plane passesthrough the distal member, and (ii) the link member extendssubstantially parallel relative to the longitudinal axis, to (2) anexpanded configuration, in moving to which (a) the first and secondplanes each move angularly, relative to the longitudinal axis, from thecollapsed configuration by between about 10 degrees and about 170degrees, and (b) the link member foreshortens along the longitudinalaxis to bias the proximal member toward the distal member; and a covermember coupled to the frame.

Clause 2. The device of Clause 1, wherein at least one of the proximalor distal members comprises an annular shape.

Clause 3. The device of Clause 2, wherein the proximal and distalmembers each comprise an annular shape.

Clause 4. The device of any of Clauses 2-3, wherein, in the collapsedconfiguration, the annular shape is positioned in an oblong, deflectedstate.

Clause 5. The device of any of Clauses 2-4, wherein, in the expandedconfiguration, the annular shape is positioned in a substantiallycircular state.

Clause 6. The device of any of Clauses 2-5, wherein the annular shapehas an expanded diameter of between about 5 mm and about 15 mm.

Clause 7. The device of Clause 6, wherein the annular shape has anexpanded diameter of between about 7 mm and about 13 mm.

Clause 8. The device of Clause 7, wherein the annular shape has anexpanded diameter of between about 8 mm and about 12 mm.

Clause 9. The device of any of Clauses 1-8, further comprising a secondlink member having a first end coupled to the proximal member and asecond end coupled to the distal member.

Clause 10. The device of Clause 9, wherein the first and second linkmembers extend in opposite directions about a periphery of the device.

Clause 11. The device of any of Clauses 9-10, wherein the first andsecond link members extend in opposite directions about a circumferenceof the device.

Clause 12. The device of any of Clauses 1-11, wherein, in the collapsedconfiguration, the first and second end sections of the proximal anddistal members are positioned substantially parallel relative to thelongitudinal axis.

Clause 13. The device of any of Clauses 1-12, wherein the proximal anddistal members each comprise a midsection and opposing first and secondend sections, and wherein the link member first end is coupled to theproximal member midsection and the link member second end is coupled tothe distal member midsection.

Clause 14. The device of any of Clauses 1-13, wherein the proximal anddistal members each comprise opposing first and second end sectionsseparated by a midsection, the longitudinal axis passing through themidsection, and wherein, in the collapsed configuration, the first andsecond end sections of the proximal and distal members are spaced at afirst distance from the longitudinal axis, and wherein, in the expandedconfiguration, the first and second sections of the proximal and distalmembers are spaced at a second distance from the longitudinal axis, thefirst distance being less than the second distance.

Clause 15. The device of Clause 14, wherein the link member first end iscoupled to the proximal member midsection and the link member second endis coupled to the distal member midsection.

Clause 16. The device of any of Clauses 1-15, wherein, in the expandedconfiguration, at least one dimension of the proximal member expandswithin the first plane and at least one dimension of the distal memberexpands within the second plane.

Clause 17. The device of Clause 16, wherein the proximal and distalmembers comprise an annular shape, wherein, in the collapsedconfiguration, the proximal and distal members are positioned in asubstantially oblong shape, and wherein, in the expanded configuration,the proximal and distal members are positioned in a substantiallycircular shape.

Clause 18. The device of any of Clauses 1-17, wherein, in the collapsedconfiguration, the first and second planes each are oriented at anglesof between about 10° and about 50° relative to the longitudinal axis.

Clause 19. The device of any of Clauses 1-18, wherein, in the collapsedconfiguration, the first and second planes each are oriented at anglesof between about 20° and about 40° relative to the longitudinal axis.

Clause 20. The device of any of Clauses 1-19, wherein, in the collapsedconfiguration, the first and second planes each are oriented at anglesof between about 25° and about 35° relative to the longitudinal axis.

Clause 21. The device of any of Clauses 1-20, wherein, in the collapsedconfiguration, the first and second planes each are oriented at an angleof about 30° relative to the longitudinal axis.

Clause 22. The device of any of Clauses 1-21, wherein, in the expandedconfiguration, the first and second planes each are oriented at anglesof between about 70° and about 110° relative to the longitudinal axis.

Clause 23. The device of any of Clauses 1-22, wherein, in the expandedconfiguration, the first and second planes each are oriented at anglesof between about 80° and about 100° relative to the longitudinal axis.

Clause 24. The device of any of Clauses 1-23, wherein, in the expandedconfiguration, the first and second planes each are oriented at anglesof between about 85° and about 95° relative to the longitudinal axis.

Clause 25. The device of any of Clauses 1-24, wherein, in the expandedconfiguration, the first and second planes each are oriented at an angleof about 90° relative to the longitudinal axis.

Clause 26. The device of any of Clauses 1-25, wherein, in the expandedconfiguration, the link member foreshortens by moving from asubstantially linear configuration to an arcuate configuration.

Clause 27. The device of any of Clauses 1-26, wherein the link member issubstantially helical shaped.

Clause 28. The device of any of Clauses 1-27, wherein the link member issubstantially U-shaped.

Clause 29. The device of any of Clauses 1-28, wherein the deviceforeshortens by over 20% when expanding from the collapsed configurationto the expanded configuration.

Clause 30. The device of any of Clauses 1-29, wherein the deviceforeshortens by over 30% when expanding from the collapsed configurationto the expanded configuration.

Clause 31. The device of any of Clauses 1-30, wherein the deviceforeshortens by over 40% when expanding from the collapsed configurationto the expanded configuration.

Clause 32. The device of any of Clauses 1-31, wherein the deviceforeshortens by over 50% when expanding from the collapsed configurationto the expanded configuration.

Clause 33. The device of any of Clauses 1-32, wherein the deviceforeshortens by over 60% when expanding from the collapsed configurationto the expanded configuration.

Clause 34. The device of any of Clauses 1-33, wherein the deviceforeshortens by over 70% when expanding from the collapsed configurationto the expanded configuration.

Clause 35. The device of any of Clauses 1-34, wherein the deviceforeshortens by over 80% when expanding from the collapsed configurationto the expanded configuration.

Clause 36. An expandable device for delivery to a target location in abody vessel, comprising: a frame comprising proximal and distal annularmembers, a first link member being coupled to the proximal and distalannular members, and a second link member being coupled to the proximaland distal annular members, wherein the frame is expandable from (1) acollapsed configuration, in which (i) the proximal and distal annularmembers are compressed into an oblong shape and oriented substantiallyparallel or oblique relative to a longitudinal axis of the frame, and(ii) the first and second link members extend substantially parallelrelative to the longitudinal axis, to (2) an expanded configuration, inwhich (a) the proximal and distal annular members are substantiallycircular and biased toward a substantially perpendicular orientationrelative to the longitudinal axis, and (b) the first and second linkmembers foreshorten along the longitudinal axis to bias the proximalannular member toward the distal annular member; and a cover membercoupled to the frame.

Clause 37. The device of Clause 36, wherein, in the collapsedconfiguration, the first and second link members have a firstlongitudinal extent, and in the expanded configuration, the first andsecond link members have a second longitudinal extent, the secondlongitudinal extent being less than the first longitudinal extent.

Clause 38. The device of any of Clauses 36-37, wherein, in the collapsedconfiguration, the proximal annular member extends along thelongitudinal axis at a first longitudinal extent that is greater than across-sectional dimension of the proximal annular member, and wherein,in the collapsed configuration, the distal annular member is extendsalong the longitudinal axis at a second longitudinal extent that isgreater than a cross-sectional dimension of the distal annular member.

Clause 39. The device of any of Clauses 36-38, wherein, in the collapsedconfiguration, the proximal and distal annular members longitudinallyoverlap each other.

Clause 40. The device of any of Clauses 36-39, wherein the first andsecond link members each comprise an arcuate body, biased to asubstantially linear shape in the collapsed configuration and to a bowedshape in the expanded configuration.

Clause 41. The device of any of Clauses 36-40, wherein the first andsecond link members comprise springs.

Clause 42. The device of any of Clauses 36-41, wherein, in the expandedconfiguration, the first and second link members are substantiallyV-shaped.

Clause 43. The device of any of Clauses 36-42, wherein, in the expandedconfiguration, the first and second link members are substantiallyU-shaped.

Clause 44. The device of any of Clauses 36-43, wherein the first linkmember is coupled to first sides of the proximal and distal annularmembers and the second link member is coupled to second sides, opposingthe first sides, of the proximal and distal annular members.

Clause 45. The device of any of Clauses 36-44, wherein the deviceforeshortens by over 20% when expanding from the collapsed configurationto the expanded configuration.

Clause 46. The device of any of Clauses 36-45, wherein the deviceforeshortens by over 30% when expanding from the collapsed configurationto the expanded configuration.

Clause 47. The device of any of Clauses 36-46, wherein the deviceforeshortens by over 40% when expanding from the collapsed configurationto the expanded configuration.

Clause 48. The device of any of Clauses 36-47, wherein the deviceforeshortens by over 50% when expanding from the collapsed configurationto the expanded configuration.

Clause 49. The device of any of Clauses 36-48, wherein the deviceforeshortens by over 60% when expanding from the collapsed configurationto the expanded configuration.

Clause 50. The device of any of Clauses 36-49, wherein the deviceforeshortens by over 70% when expanding from the collapsed configurationto the expanded configuration.

Clause 51. The device of any of Clauses 36-50, wherein the deviceforeshortens by over 80% when expanding from the collapsed configurationto the expanded configuration.

Clause 52. The device of any of Clauses 36-51, further comprising anintermediate annular member coupled to the first and second link membersintermediate the proximal and distal annular members.

Clause 53. The device of any of Clauses 36-52, the first and second linkmembers are coupled to the proximal annular member at first and secondcoupling points and to the distal annular member at third and fourthcoupling points, wherein the first and second coupling points are spacedfurther apart from the third and fourth coupling points in the collapsedconfiguration and in the expanded configuration.

Clause 54. The device of any of Clauses 36-53, wherein the proximal anddistal annular members have expanded diameters of between about 5 mm andabout 15 mm.

Clause 55. The device of Clause 54, wherein the proximal and distalannular members have expanded diameters of between about 7 mm and about13 mm.

Clause 56. The device of Clause 55, wherein the proximal and distalannular members have expanded diameters of between about 8 mm and about12 mm.

Clause 57. The device of any of Clauses 36-56, wherein the device has alongitudinal length in the expanded configuration of between about 3 mmand about 12 mm.

Clause 58. The device of Clause 57, wherein the device has alongitudinal length in the expanded configuration of between about 4 mmand about 10 mm.

Clause 59. The device of Clause 58, wherein the device has alongitudinal length in the expanded configuration of between about 5 mmand about 7 mm.

Clause 60. A delivery system for delivering an occlusive device to atarget vessel, the system comprising: a handle portion; a tubular shaftcomprising a proximal end, coupled to the handle portion, and a distalend, comprising a lumen; a delivery component slidably disposed withinthe lumen and configured to advance an occlusive device within the lumenfor delivery to the target vessel; an actuation component coupled to thehandle portion and the delivery component for selectively advancing orretracting the delivery component relative to the shaft; and a releasemember coupled to the delivery component, the release member beingmovable between an engaged position in which the release member engagesthe occlusive device relative to the delivery component, and adisengaged position, in which the occlusive device is disengaged fromthe delivery component.

Clause 61. The system of Clause 60, wherein the shaft comprises a needlehaving a beveled tip.

Clause 62. The system of any of Clauses 60-61, wherein the lumen isbetween about 3 Fr and about 9 Fr.

Clause 63. The system of Clause 62, wherein the lumen is between about 4Fr and about 8 Fr.

Clause 64. The system of Clause 63, wherein the lumen is between about 5Fr and about 7 Fr.

Clause 65. The system of any of Clauses 60-64, wherein the shaft has alength of between about 8 cm to about 15 cm.

Clause 66. The system of Clause 65, wherein the shaft has a length ofbetween about 10 cm to about 12 cm.

Clause 67. The system of any of Clauses 60-67, wherein the deliverycomponent is configured to support an occlusive device along an outersurface thereof.

Clause 68. The system of any of Clauses 60-68, wherein the deliverycomponent comprises a hollow tubular member.

Clause 69. The system of any of Clauses 60-69, wherein the deliverycomponent comprises an atraumatic tip.

Clause 70. The system of Clause 69, wherein the delivery componentcomprises a rounded tip.

Clause 71. The system of Clause 69, wherein the tip comprises asubstantially rounded conical shape.

Clause 72. The system of any of Clauses 69-71, wherein the tip isconfigured to support the device thereon.

Clause 73. The system of any of Clauses 60-72, wherein the releasemember comprises a wire extending through a lumen of the deliverycomponent, the wire configured to engage at least one portion of adevice supported on the delivery component.

Clause 74. The system of Clause 73, wherein the wire engages the devicein two locations along the delivery component.

Clause 75. The system of Clause 74, wherein the delivery componentcomprises proximal and distal slots into which first and second portionsof the device can be coupled with the wire.

Clause 76. A method of implanting an occlusive device, comprising:advancing a needle subcutaneously and into a target vessel, the needlehaving a lumen in which an occlusion device is disposed, the devicecomprising any of the devices recited in Clauses 1 to 59; and advancingthe device out of the lumen to release the device into the targetvessel.

Clause 77. The method of Clause 76, wherein the advancing comprisesadvancing the needle into a perforator artery.

Clause 78. The method of Clause 77, wherein the perforator vesselextends between a deep vein and a superficial vein in a limb of apatient.

Clause 79. The method of any of Clauses 77-78, wherein the perforatorvessel comprises a thigh perforator, a knee perforator, a legperforator, an ankle perforator, or a foot perforator.

Clause 80. The method of any of Clauses 77-79, wherein the perforatorvessel comprises one of a Hunterian perforator, a Dodd perforator, aBoyd perforator, a Cockett perforator, a fibular perforator.

Clause 81. The method of any of Clauses 77-80, wherein the perforatorvessel has a length of less than 10 cm.

Clause 82. The method of any of Clauses 77-81, wherein the perforatorvessel has a length of less than 7 cm.

Clause 83. The method of any of Clauses 77-82, wherein the perforatorvessel has a length of less than 5 cm.

Clause 84. The method of any of Clauses 76-83, wherein the advancingcomprises advancing a delivery component from within the needle toexpose the device within the vessel.

Clause 85. The method of Clause 84, further comprising, after advancingthe delivery component from within the needle, proximally retracting anactuation component relative to the delivery component to release thedevice.

Clause 86. The method of Clause 85, wherein the proximally retractingcomprises sequentially disengaging first and second portions of thedevice.

Clause 87. A method of implanting an occlusive device in a perforatorvessel, the method comprising: introducing a needle through skin of apatient; advancing the needle into a perforator vessel, the perforatorvessel extending between a superficial vein and a deep vein; distallyadvancing a delivery component from within the needle until a distal endof the delivery component extends into the deep vein; releasing a distalportion of the occlusive device into the deep vein; proximallywithdrawing the needle from the perforator vessel such that the deviceis exposed within the vessel; and releasing a proximal portion of thedevice into the superficial vein such that the device blocks flowthrough the vessel.

Clause 88. The method of Clause 87, wherein the releasing the distalportion comprises proximally retracting an actuation component relativeto the delivery component to disengage the distal portion from thedelivery component.

Clause 89. The method of any of Clauses 87-88, wherein the releasing theproximal portion comprises proximally retracting an actuation componentrelative to the delivery component to disengage the proximal portionfrom the delivery component.

Clause 90. The method of any of Clauses 87-89, wherein upon releasingthe proximal portion, the device foreshortens within the perforatorvessel.

Clause 91. The method of any of Clauses 87-90, wherein the advancingcomprises guiding the needle using an imaging component.

Clause 92. The method of Clause 91, wherein the imaging componentcomprises a handheld ultrasound device

Clause 93. The method of any of Clauses 87-92, wherein the introducingcomprises introducing the needle through a from moral or jugular accesspoint.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the subject technology and are incorporated in andconstitute a part of this specification, illustrate aspects of thesubject technology and together with the description serve to explainthe principles of the subject technology.

FIG. 1A is a perspective view of an occlusive device implanted in aperforator vessel, according to some embodiments.

FIGS. 1B-1F are views of vasculature in a patient, which can representtarget vessels that can be treated, according to some embodiments.

FIGS. 2A and 2B are perspective views of occlusive devices in anexpanded state, according to some embodiments.

FIGS. 3A-3C illustrate sequential steps in releasing the occlusivedevice of FIG. 2A from engagement with a catheter, according to someembodiments.

FIGS. 4A-4B illustrate side views of the engagement between the proximaland distal end portions of the occlusive device as shown in FIG. 3A.

FIG. 5 is a side, cross-sectional view of a deployment system comprisinga needle, a catheter, and an occlusive device, according to someembodiments.

FIGS. 6A-6D illustrate sequential steps in implanting an occlusivedevice in a perforator vessel, according to some embodiments.

FIG. 7 is a perspective view of another occlusive device in an expandedstate, according to some embodiments.

FIGS. 8A-8C illustrate sequential steps in releasing the occlusivedevice of FIG. 5 from engagement with a catheter, according to someembodiments.

FIG. 9A illustrates a perspective view of an occlusive device in anexpanded position, according to some embodiments.

FIG. 9B illustrates a perspective view of an occlusive device in acollapsed position, according to some embodiments.

FIGS. 10A-10C illustrate sequential steps in releasing an occlusivedevice from engagement with a catheter, according to some embodiments.

FIGS. 11A-11C illustrate sequential steps in releasing an occlusivedevice from engagement with a catheter, according to some embodiments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. Itshould be understood that the subject technology may be practicedwithout some of these specific details. In other instances, well-knownstructures and techniques have not been shown in detail so as not toobscure the subject technology.

While the present description sets forth specific details of variousembodiments, it will be appreciated that the description is illustrativeonly and should not be construed in any way as limiting. It iscontemplated that although particular embodiments of the presentinventions may be disclosed or shown in particular contexts, suchembodiments can be used in a variety of endoluminal applications.Various applications of such embodiments and modifications thereto,which may occur to those who are skilled in the art, are alsoencompassed by the general concepts described herein.

The present disclosure provides various embodiments of an expandabledevice, such as a stent, and a catheter for supporting and deliveringthe stent, as well as methods of using the devices and catheters.

According to some embodiments, an occlusion system can quickly andreliably close vessels (veins or arteries) such as incompetent venousperforators and arterial venous fistulae. Some embodiments can beperformed using minimally invasive techniques that allow a clinician toprovide rapid and effective treatment for a variety of vascularconditions.

For example, some methods can be provided in which a clinicianpenetrates percutaneously to a target vessel using a delivery system.The delivery system can comprise a catheter configured to access thetarget vessel. In some embodiments, the catheter can be a short needle.The percutaneous access can be made at a point closest to the targetvessel, such as a perforator-hemorrhage site. Further, in someembodiments, an ultrasound device (such as a handheld ultrasound device)can be used as a visualization tool to facilitate placement of theneedle within the target vessel.

Further, some methods can be provided in which a clinicianpercutaneously accesses a target vessel using a catheter. The cathetercan be guided to the proper location in the target vessel usingimage-guided endovascular placement. The catheter can be used to delivera device that closes or occludes the target vessel.

According to some embodiments, devices, catheters, systems, and methodsdisclosed herein can be used for percutaneous, peripheral occlusion ofthe arterial and venous vasculature. For example, some embodiments canbe used to treat pelvic venous incompetence, varicocele, gonadal veinfor pelvic varices in females with chronic pelvic pain, stop blood lossfrom a damaged blood vessel due to a traumatic arterial injury, stophemorrhage caused by a neoplasia, and close an abnormal blood vessel orblood vessels supplying a vascular anomaly such as arteriovenousmalformations or arteriovenous fistulas, and other conditions.

According to some embodiments, devices, catheters, systems, and methodsdisclosed herein can also be used for percutaneous, peripheral stentingof the arterial and venous vasculature.

Some embodiments disclosed herein can be used to treat variousinsufficiencies in the vasculature. For example, some embodiments can beused to treat venous insufficiencies in a variety of vessels of thevenous anatomy, such as between deep veins and perforator veins,including the common femoral, the deep femoral, the external iliac, thefemoral, the popliteal, the anterior and/or posterior tibial, and theperoneal veins.

The venous system comprises superficial veins, deep veins, andperforator veins that fluidly interconnect the superficial veins withthe deep veins. Deep veins are located within the muscle fascia andallow a high volume and pressure of blood to pass therethrough,accounting for approximately 90-95% of venous blood return to the heart.Perforator veins connect the superficial and deep venous networks in theextremities, draining blood to the deep veins as part of the process ofreturning oxygen-depleted blood to the heart.

Perforator veins have one-way valves designed to prevent backflow ofblood down towards the superficial veins. When those valves no longerfunction properly and reflux occurs, the buildup of blood and pressurecan cause not only the superficial veins but the perforators themselvesto become incompetent. Perforator veins in the lower leg and ankle areparticularly vulnerable to distention and incompetence, and theresultant circulatory problems create an increased likelihood of edema,skin discoloration, dermatitis and skin ulcers in the immediate area.Perforator vessels can include: thigh perforators (perforators of thefemoral canal and inguinal perforators); knee perforators (medial,lateral, supra-, and infrapatellar and popliteal fossa perforators); legperforators (medial perforators (paratibial and lower, middle and upperposterior tibial), lateral perforators, anterior perforators, posteriorperforators (gastrocnemius, intergemellar, and para-Achillean)); ankleperforators (medial, lateral, and anterior perforators); and footperforators (medial, lateral, dorsal, and plantar perforators).

Superficial veins serve to drain blood from the skin. Blood travels fromthe superficial veins through the perforator veins to the deep veins.Superficial veins are located near the surface of the skin, outside ofthe muscle fascia, and they account for approximately 5-10% of venousblood return to the heart. There are two primary superficial veins: thesmall saphenous vein (SSV) and the great saphenous vein (GSV).

In accordance with some embodiments, a medical implant can be providedthat can be used in a variety of clinical applications, such as vesselocclusion, stenting, or other functions within a body vessel. Themedical implant can comprise a frame and one or more secondarycomponents.

The frame can comprise one, two, or more resilient members, such aswires, rings, coils, and other components, which can be drawn out into adelivery configuration in which the frame is in a collapsedconfiguration and thereafter expands to an expanded state when releasedfrom a delivery device, such as a catheter.

Referring now to the figures, FIG. 1 illustrates an embodiment of animplant device 100 that can be delivered to a target location foroccluding a blood vessel or body lumen. FIG. 1 illustrates a schematiccross-sectional view of a leg 90 that has a varicose vein 92. Thevaricose vein 92 can be a superficial vein that is interconnected to adeep vein 94 by a perforator vein 96. As illustrated, some embodimentscan be used to treat varicose veins by be implanted into a perforatorvein 102 that has a faulty valve. After the implant 100 is implantedinto the perforator vein 102, the perforator vein 102 can be occluded,thus preventing any backflow through the perforator vein 102 andreducing or eliminating the varicose vein.

FIGS. 1B-1F illustrate schematic views of the vasculature within thelegs of a human. As discussed herein, some embodiments of the system anddevices can be used to treat varicose veins, such as by treating orclosing incompetent venous perforators, or other circulatoryafflictions, such as arteriovenous fistulae (AVF), and others. Theillustrations in FIGS. 1B-1F provide further detail to illustratepotential target vessels or target areas within the legs of a patient.

FIG. 2A-2B illustrate embodiments of the implant device 100, 100′. Inreferring to these embodiments, reference to FIG. 2B will be understoodas referring to each element or feature as a “prime” of the mentionedfeature (e.g., a device 100, 100′ or frame member 202, 202′), except asotherwise indicated. The implant device can comprise a frame member 202and an occlusive member 204. The frame member 202 can be used to anchorthe occlusive member 204 within the target vessel or body lumen.

In some embodiments, the device 100 can comprise two or more supportmembers that are coupled to at least one link member. Further, the framemember 202 can be self-expandable. In some embodiments, the frame member202 can also be expandable under the application of force (such as by aballoon), or by electricity or heat (such as by reaching a transitiontemperature less than the temperature of the human body).

The frame member 202 can comprise a proximal support member 210, adistal support member 212, and at least one link member 214 extendingbetween the proximal and distal members 210, 212. The link member 214can be coupled to the proximal member 210 and the distal member 214 atrespective first and second ends 220, 222 of the link member 214.

As shown in FIGS. 2A-2B, some embodiments can be configured to comprisea first link member 214 and a second link member 216. The second linkmember 216 can be coupled to the proximal and distal members 210, 212 atrespective first and second ends 224, 226 of the second link member 216.

In some embodiments, the frame member can also comprise a variety ofstructures, including a coil that follows a helical path. Variousembodiments that can be used in accordance with the inventions disclosedherein are disclosed in Applicant's co-pending patent applications: U.S.patent application Ser. No. 12/826,593, filed on Jun. 29, 2010; U.S.patent application Ser. No. 13/367,338, filed on Feb. 6, 2012; U.S.Patent Pub. No. US20120095489, published on Apr. 19, 2012; U.S. patentapplication Ser. No. 13/828,974, filed on Mar. 14, 2013, U.S. patentapplication Ser. No. 14/044,794, filed on Oct. 2, 2013; U.S. Patent App.No. 61/835,406, filed on Jun. 14, 2013; U.S. Patent App. No. 61/904,376,filed on Nov. 14, 2013; U.S. Patent App. No. 61/904,379, filed on Nov.14, 2013; U.S. Patent App. No. 61/835,461, filed on Jun. 14, 2013; U.S.Patent App. No. 61/900,321, filed on Nov. 5, 2013; and U.S. patentapplication Ser. No. 14/101,171, filed on Dec. 9, 2013, the entiretiesof which are incorporated herein by reference.

The occlusive member 204 can be coupled to the frame member 202 can beconfigured to facilitate at least partial occlusion of the target vesselinto which the device 100 is placed. In some embodiments, the occlusivemember 204 can comprise an ePTFE membrane or cap that extends aroundand/or is coupled to the frame member 202.

The occlusive member 204 can comprise a proximal end portion 230 and adistal end portion 232. At least one of the proximal end portion 230 andthe distal end portion 232 can be coupled to the frame member 202. Forexample, in some embodiments, the occlusive member 204 can be coupled tothe frame member 202 and/or be configured as illustrated in applicant'sco-pending patent application Ser. No. 14/101,171, filed Dec. 9, 2013(084988-0046); Ser. No. 14/044,794, filed on Oct. 2, 2013 (084988-0039);and Ser. No. 13/828,974, filed on Mar. 14, 2013 (084988-0030), theentirety of which is incorporated herein by reference.

The frame member 202 is illustrated in the expanded state 240 in FIG.2A-2B. According to some embodiments, the frame member 202 can beresiliently deflectable from the expanded state 240 to a collapsed state242, illustrated in FIG. 3A. Other embodiments illustrated in thefigures demonstrate the change from the collapsed state to the expandedstate, and similar principles of operation can be implemented in yetadditional embodiments.

According to some embodiments, the collapsed state of the device canenable the device to be delivered to a target vessel in a low profilesize. Subsequently, the device can expand, such as by self-expansion orotherwise, in order to be released and anchored in the target vessel.

Some embodiments can be configured such that proximal and/or distal endportions of the implant expand to a diameter much greater than adiameter of a central portion of the implant such that expansion of theimplant reduces or eliminates one or more degrees of motion of thedevice relative to surrounding vasculature.

For example, as illustrated in FIG. 1A, proximal and distal end portions110, 112 of the device 100 have been expanded radially relative to acentral portion 114 of the device 100. Thus, when placed in theperforator vein 96, the distal end portion 112 of the device 100 can bereleased and expanded into the deep vein 94 and the proximal end portion110 of the device 100 can be released and expanded into the superficialvein 92, thus causing the central portion 114 of the device 100 toreside within the perforator vein 96. This expansion of the device 100can provide partial or full occlusion of the perforator vein 96.

In some embodiments, the device can be configured to be resilientlybiased toward an expanded configuration. Thus, the device can be loadedonto a catheter or other delivery mechanism in a delivery or collapsedconfiguration and, when released, be expanded or spring back to theexpanded configuration in the target vessel.

Further, in accordance with some embodiments, the one or more linkmembers can be configured to exert an active foreshortening forcebetween the proximal and distal end portions when the device is in theexpanded configuration.

The one or more link members can be shaped in way that upon release fromthe delivery mechanism, each link member tends to bring opposing supportmembers together as close as possible by springing back or reboundinginto a predetermined V or parabola shape. Thus, in the collapsedconfiguration, each link member can be elongated or stretched along thelongitudinal axis in a state of tension. When the device is releasedfrom constraint and allowed to expand towards the expandedconfiguration, each link member can return to a predetermined shape,causing the length of the device to become foreshortened.

For example, in the embodiment illustrated in FIG. 1, the centralportion 114 of the implant 100 can comprise one or more link membersthat tend to draw the proximal and distal end portions 110, 112 towardeach other, thus foreshortening the length of the implant 100. In thismanner, the device 100 can be placed at a target vessel (shown as aperforator vessel 96) and longitudinally contract in order to moresecurely engage the target vessel, provide better occlusion of thetarget vessel, and reduce obstruction of adjacent vessels (such as thesuperficial and deep vessels 92, 96).

Some embodiments can foreshorten by between about 10% and about 90% ofthe length of the device 100 in the collapsed state 242. The collapsedlength of the device 100 can be measured either using the furthestpoints of opposing ends or using the points at which the link member(s)interconnects with the proximal and/or distal members.

The length of each link member as set and deployed, which can determinethe distance between adjacent rings in the expanded configuration(manifesting the vessel closure position) can be between about 3 mm andabout 20 mm, between about 4 mm and about 15 mm, between about 6 mm andabout 12 mm, between about 8 mm and about 10 mm, or between about 4 mmand about 10 mm. Accordingly, in the collapsed configuration, the lengthof each link member can be correspondingly increased based on thegeometry of the link member in the expanded configuration versus in thecollapsed configuration.

In some embodiments, in the expanded configuration, a length of theframe member 202 may be between about 7 mm and about 15 mm, betweenabout 8 mm and about 12 mm, or between about 9 mm and about 10 mm.

As illustrated in embodiments disclosed herein, the device can comprisetwo or more link members. The link members can, when seen in side view,have a generally V or parabolic shape. The link members can extendhelically about the periphery, outer surface, or circumference of thedevice. In some embodiments, a path of a link member can reversedirection, such as a helical path reversing pitch, as the link memberextends between support members.

For example, as illustrated in FIG. 2A-2B, the link members 214, 216 canbe configured to extend about the periphery or circumference of theframe member 202. FIG. 2A illustrates that the link members 214, 216 canextend about the periphery or circumference of the frame member 202 insubstantially parallel helical directions. FIG. 2A also illustrates thatthe pitch of the helical direction can be reversed, for example, atabout a midpoint of the link member. Further, as illustrated in FIGS. 2Band 5, the link members can be configured to extend about the peripheryor circumference of the frame member in substantially opposite helicaldirections.

In accordance with some embodiments, in order to achieve the expandedstate 240, the frame member 202 can be configured such that interactionsbetween its component parts and material properties of the componentparts tend to create a preferred or default position to which the framemember 202 resiliently expands. Further, in some embodiments, the framemember 202 can be deflectable and deformable from the collapsedconfiguration to the expanded configuration in order to deliver thedevice to the target vessel.

In some embodiments, a first plane passing through the proximal member210 and a second plane passing through the distal member 212 can eachundergo a rotational or angular movement relative to the longitudinalaxis when the frame member 202 moves from the collapsed configuration242 to the expanded configuration 240. This movement is shown generallyin FIGS. 3A-3C.

For example, in the collapsed configuration 242, the frame member 202can be configured such that at least one of the proximal member 210 orthe distal member 212 extends substantially parallel or oblique relativeto a longitudinal axis of the device 100. When the proximal member 210and/or the distal member 212 move(s) from the collapsed configuration242 to the expanded configuration 240, the first and/or second plane(s)can move angularly or rotate relative to the longitudinal axis. Forexample, as illustrated in FIGS. 4A-4B, a first plane 280 can passthrough the proximal member 210, and a second plane 282 can pass throughthe distal member 212. When the implant 100 is released from thecollapsed configuration 242 to the expanded configuration 240, the firstand second planes 280, 282 can move or rotate relative to thelongitudinal axis 290. For example, in some embodiments, the first andsecond planes 280, 282 can be substantially perpendicular relative tothe longitudinal axis 290.

The first and/or second planes can be arbitrary planes that correspondto the respective proximal and distal members. The location ororientation of the planes relative to the members can each be determinedbased on shape, size, or other characteristics of the members. Forexample, the planes can each pass through a maximal amount or mass ofthe respective members. Further, the planes can also be defined by oneor more surface features of the members. For example, if the memberscomprise planar annuli, a top or bottom surface of each annulus canserve to define the extent of the plane.

The degree of rotation or angular movement of the first and/or secondplanes can be between about 10° and about 170°, including any of theangular ranges or angles therebetween, which will not be listed here forbrevity.

For example, plane(s) passing through the proximal or distal member canbe oriented within about 45° or less of the longitudinal axis when inthe collapsed configuration 242. For example, as illustrated in FIGS.4A-4B, a first plane 280, passing through the proximal member 210, and asecond plane 282, passing through the distal member 212, can each beoriented within about 45° or less of the longitudinal axis 290. Theangle of the planes is shown as element 292 in FIGS. 4A-4B.

The degree of rotation or angular movement, as well as the degree offoreshortening, can be measured based on the movement of the proximaland/or distal members outside of the body or when placed in situ.

In accordance with some embodiments, the support members (e.g., theproximal and distal members 210, 212) can be configured to pop uppost-deployment in order to provide reliable closure of the targetvessel or hole. Further, because a target vessel may be fairly short(such as in the case of a venous perforator vessel), the device can beconfigured to draw opposing ends thereof into a foreshortenedconfiguration. The support members can comprise rings that can be madeas solid shapes or as open spirals.

Each support member can have a maximum cross-sectional dimension ofbetween about 6 mm and about 20 mm. In some embodiments, the maximumcross-sectional dimension can be between about 8 mm and about 16 mm,between about 10 mm and about 15 mm, between about 12 mm and about 14mm, between about 8 mm and about 12 mm, or between about 10 mm in 15 mm.In some embodiments, each support member can be configured as a circularor annular shape. Accordingly, a support member can define a diameter inany of the above-noted ranges. Further, the support member can bedeflectable and the maximum cross-sectional dimension can represent themaximum cross-sectional dimension of the support member in the expandedconfiguration. Therefore, the support member can be deflected such thata deflected cross-sectional dimension in the collapsed configuration isgreater than the maximum cross-sectional dimension in the expandedconfiguration.

In the expanded configuration, a cross-sectional dimension of theproximal and distal end portions of the device (due to thecross-sectional dimension of the corresponding support member) can begreater than a cross-sectional dimension of a central portion of thedevice. For example, a cross-sectional dimension of the central portion114 can be between about 2 mm and about 10 mm. Thus, when in theexpanded configuration, the central portion 114 can have across-sectional dimension that is less than the cross-sectionaldimensions of the proximal and/or distal end portions of the device.Such an embodiment as illustrated in FIGS. 1 and 8A-8D. The embodimentsillustrated in FIGS. 2A-2B, 3C, 5, 6C, and 9C are shown in expandedconfigurations that are not deployed into or constrained by acorresponding target vessel geometry. When implanted into acorresponding target vessel, the geometry of the target vessel can tendto constrict the cross-sectional dimension of the device in the centralportion thereof, as shown in FIGS. 1 and 8A-8D.

Delivery of the implant device can be performed using a delivery systemthat maintains the implant device in a constrained or collapsedconfiguration while being advanced to the target area. The deliverysystem can carry the implant device in the collapsed configuration untilreaching the target area and thereafter be actuated to release theimplant device at the target area. The actuation of the delivery systemcan be performed in accordance with some of the embodiments disclosedherein. Further, in accordance with some embodiments, the deliverysystem can comprise a catheter or a needle delivery member.

As illustrated in FIGS. 3A-4B, the frame member 202 of the device 100(referring to the embodiment in FIG. 2A, although any of the embodimentsdisclosed herein can be used with any of the delivery systems disclosedherein) can be configured to be supported or engaged by a distal end ofa catheter 300. The catheter 300 can comprise at least one notch thatfacilitates engagement between the frame member 202. The frame member202 comprises proximal and distal members 210, 212 that can be engagedwithin the respective proximal and distal notches 302, 304. For example,the delivery system can comprise an actuation wire 310 that can extendthrough a lumen of the catheter 300 in order to engage the respectiveproximal and distal members 210, 212.

The actuation and function of the delivery system can incorporatefeatures disclosed in Applicant's co-pending patent application Ser. No.14/101,171, filed Dec. 9, 2013 (084988-0046); Ser. No. 14/044,794, filedon Oct. 2, 2013 (084988-0039); and Ser. No. 13/828,974, filed on Mar.14, 2013 (084988-0030), the entireties of each of which are incorporatedherein by reference.

According to some embodiments, the device can be engaged, supported,and/or housed along a distal portion of the system. Some embodiments canadvantageously provide a needle delivery member that has a smallcross-sectional profile.

For example, the needle or needle delivery member can comprise a needleprofile that defines an outer diameter from about 3 Fr, 4 Fr, 5 Fr, 6Fr, 7 Fr, 8 Fr, or 9 Fr, as noted in Table 1 below and discussed furtherherein.

TABLE 1 French Diameter Diameter Gauge (mm) (inches) 3 1 0.039 4 1.330.053 5 1.67 0.066 6 2 0.079 7 2.3 0.092 8 2.7 0.105 9 3 0.118

FIG. 5 illustrates an embodiment of a delivery system 400 for deliveringan implant device to a target vessel. The delivery system 400 cancomprise a needle component 402 and a catheter 404 that is slidablymounted within a lumen 406 of the needle component 402. The catheter 404can support an implant device 410 in the manner described above withrespect to FIGS. 3A-3B.

As illustrated in FIG. 5, the system 400 can comprise a handle portion420 that is coupled to the needle component 402. The handle portion 420can comprise an actuating mechanism 422 that can be operative to controlproximal or distal movement of the catheter 404. Additionally, thehandle portion can comprise an implant release component 424 that can becoupled to a proximal end of the actuation wire 310 (shown in FIGS.3A-3C).

In use, the delivery system 400 can be advanced to a target vessel, suchas an incompetent perforator vessel that is to be closed. The needlecomponent 402 can be advanced into the tissue of the patient anddelivered as illustrated in FIGS. 6A-6D.

As shown in FIGS. 6A-6B, the delivery system 400 can be introducedthrough the skin 450 with image guidance provided by a hand heldultrasound system 452. For example, in some embodiments, a scope, vesselfinder, or vessel transiluminator, such as a Venoscope®, can be used tolocate the target veins or arteries. A guidewire can be introduced intoa superficial vein 460, which can be used to facilitate introduction ofa needle component 402. The needle component 402 can be advanced intothe superficial vein 460 toward a perforator vein 462 that interconnectsthe superficial vein 460 with a deep vein 464. FIG. 6B illustrates thatonce the needle component has been guided into the perforator vein 462,the catheter 404, with the implant 410 supported thereon, can beadvanced until a distal end 470 of the catheter 404 enters or ispositioned adjacent to the deep vein 464. The distal end 470 can beadvanced until it is positioned within the deep vein 464, adjacent to aninner wall 466 of the deep vein 464, or at least is placed deep insideof the perforator vein 462, which can be aided by ultrasoundvisualization.

Once the distal end 470 of the catheter 404 is in the proper positionwithin the deep vein 464, the implant distal portion 412 can be releasedfrom engagement with the catheter 404. In order to release the implantdevice 410, the distal end portion 412 can be released as shown in FIG.6C. Thereafter, a proximal end portion 414 of the implant device 410 canbe released and permitted to expand into the superficial vein 460. Theneedle component 402 thereafter can be proximally withdrawn out of theperforator vein 462, as illustrated in FIGS. 6C-6D. As the implantdevice 410 moves towards its expanded configuration, the proximal anddistal end portions 412, 414 can be drawn together by virtue of theforeshortening created by the link member(s) of the implant device 410.Thus, closure of the perforator vein 462 can occur immediately orinstantaneously after release of the proximal end portion 414 of thedevice 410.

In case of occlusion of AVF, the delivery system can be configuredsimilarly to that described above with respect to FIGS. 5-6D. Thedelivery system can optionally deliver the implant device using acatheter and image guided endovascular intervention. For example, thedelivery system in the case of AVF can achieve access throughtraditional pathways, such as the femoral or jugular artery, or otherappropriate pathways, and be advanced toward the target area. In suchembodiments, the profile of the catheter can be about 3 Fr, 4 Fr, 5 Fr,6 Fr, or 7 Fr.

Referring now to FIGS. 7-8C, another occlusive device 500 is shown inexpanded and collapsed configurations, and in relationship to a catheter300 on which the device 500 can be supported. The device 500 comprisesproximal and distal members 510, 512 and a pair of link members 520,522. The link members 520, 522 can be coupled to the proximal and distalmembers 510, 512 and extend in a helical direction about the peripheryor circumference of the device 500. As shown, the link members 520, 522can extend in opposing helical directions. However, as illustrated inthe embodiment shown in FIG. 2A, some embodiments can be configured suchthat the link members extend in the same helical direction. Additionaldetails and features related to the operation and interaction of thedevice 500 with the catheter during expansion or release of the device500 similar to those described above with respect to FIGS. 3A-3C andwill not be repeated here and for brevity.

FIGS. 9A-9B illustrate perspective views of another embodiment of anocclusive device 600, in an expanded configuration 602 and in acollapsed configuration 604. The device 600 can comprise a proximalmember 610 and a distal member 612, as well as an occlusive member 614.The proximal and distal members can be interconnected by at least onelink member 620. The device 600 can incorporate many of the features andadvantages discussed above with respect to the devices shown in FIGS.1-8C, in such features will not be discussed here and for brevity.

The link member 620 can be configured to rebound or assume a U- orV-shaped configuration when in the expanded configuration 602. Thedevice can be coupled to a catheter 650 and released there from whendelivered to the target vessel, as illustrated in FIGS. 10A-10C.

In accordance with some embodiments, in order to facilitate engagementwith the catheter 650, the device 600 can comprise proximal and distalapertures 660, 662 configured to be engaged with an actuation wire 652at respective first and second slots 670, 672 of the catheter 650. Theimplant device 600 can be coupled to the catheter as illustrated in FIG.10A. In order to release the device 600, the actuation wire 652 can beproximally withdrawn within the catheter 650 until the distal andproximal members 612, 610 are sequentially released from engagement withthe catheter 650. This embodiment can provide the advantageous functionsillustrated in discussed above with respect to the other devices anddelivery systems.

In accordance with yet another embodiment, FIGS. 11A-11C illustratesequential steps in releasing an occlusive device 700 from engagementwith a catheter 710. The device 700 is configured as discussed abovewith respect to the device 100′ shown in FIG. 2B. Accordingly, thediscussion herein for the device 100′ is incorporated here and will notbe repeated for brevity. FIGS. 11A-11C illustrate another deliverymethod or system that can be employed in delivering an implant device toa target region.

As shown in FIG. 11A, the device 700 can be loaded onto the catheter 710without having the device 700 and the catheter 710 or otherwise requirethe catheter 710 to be inserted into an inner volume of the device 700.As such, the device 700 can be carried on only a portion of the outersurface of the catheter 710. In the illustrated embodiment, the catheter710 is shown as a hollow, tubular catheter; however, the catheter 710can be replaced by a flat delivery substrate or solid core member whosesize can be further decreased in order to access small vessels whileproviding a sufficiently rigid structure against which the device can besupported in a collapsed configuration. Sufficient rigidity is necessaryin order to prevent the catheter or support device from bending inresponse to the bias force exerted by the link member(s) of the device.

According to various embodiments of the subject technology, the supportframe may comprise at least one of stainless steel, nickel titanium(NiTi), cobalt chromium (CoCr), titanium, a polymer, a polyester basedmaterial, a tyrosine based polycarbonate, a polyethylene based material,Teflon (e.g., including expanded Teflon), and other suitable materialsknown to those of ordinary skill in the art. In some embodiments, thesupport frame may comprise at least one of polyethylene, polyglicolide,polylactide, ε-caprolactone, polycarbonate, hydroxyalkanote, paradioxinine, polytetrafluoroethylene (PTFE), expandedpolytetrafluoroethylene (ePTFE), PLA, PGA, PLLA, PDLLA, PDO, PCL, andother suitable materials known to those of ordinary skill in the art. Insome embodiments, the support frame and/or occlusion membrane maycomprise a bioabsorbable material, beneficially allowing for theircontrolled degradation. In some embodiments, the support frame and/orocclusion membrane may be formed of bioabsorbable material to have acontrolled degradation anywhere between about 3 months to about 3 yearsdepending on the desired application of support frame. In someembodiments, the controlled degradation may be less than about 3 monthsor greater than about 3 years. For example, hydrolysis of ester linkagesor effects of enzymatic degradation may be utilized for the controlleddegradation.

According to various embodiments of the subject technology, occlusionmembrane may be used to occlude, partially or completely, luminalstructure in which an implant is deployed. In some embodiments as usedherein, occlusion may refer to either partial or complete occlusion.Some embodiments can be deployed in vessels having dimensions of betweenabout 3 mm to about 20 mm. This exceptional and advantageous ability ofembodiments of the medical implants disclosed herein to provide stentingin such small vessels is made possible, for example, due to the minimaldelivery profile can be achieved using such embodiments. The targetdelivery profile can be about 8 Fr or smaller. Further, some embodimentscan optionally comprise a fibrous membrane component, in variousclinical applications, as discussed above. According to someembodiments, implants disclosed herein having a fibrous membrane featurecan have an expanded diameter of between about 3 mm to about 22 mm.

According to various aspects of the subject technology, implantsdisclosed herein may be used for various applications for reducing orstopping flow through a luminal structure in a patient. Implants of thesubject technology may be used for rapid, well-controlled, and reliableocclusion of luminal structures. For example, the luminal structure maycomprise at least one of a blood vessel, a body organ, a lung, anairway, a Fallopian tube, a cervical canal, a vagina, a cervix, a vasdeferens, a bronchus, a ureter, a colon, a rectum, an anus, a bio duct,a pancreatic duct, or other suitable tubular structures known to thoseof ordinary skill in the art. Some embodiments can be used to close aductus arteriosis from a patent ductus arteriosis. In some embodiments,implants of the present disclosure may be used for temporary occlusionin cases of lung disease, or for temporary occlusion of femalereproductive organs for contraceptive purposes. In some embodiments,implants of the present disclosure may be removed, or flow may berestored through the luminal structure to restore original organfunctions.

In some embodiments, implants of the present disclosure may be used forvarious endoluminal occlusion procedures, including procedures for thelungs (e.g., selective endobronchial occlusion for lung reduction,occlusion of bronchopleural or bronchocutaneous fistulas, endovascularocclusion of pulmonary AVMs and fistulas or aortopulmonary anastomoses)and procedures for reproductive organs (e.g., endoluminal occlusion ofvas deferens or Fallopian tubes for minimally-invasive contraceptiveintervention, endovascular occlusion of varicocele in males and lowabdominal gonadal veins for reducing or completely eliminating chronicpelvic pain syndrome in females). In some embodiments, implants of thepresent disclosure may be used for reducing or stopping blood loss froma damaged blood vessel, closing an abnormal blood vessel or a bloodvessel supplying a vascular anomaly, or interrupting blood supply to anorgan or part of an organ for permanent devascularization (e.g., closureof splenic artery in spleen laceration, devascularization of tissuesinvolved by neoplastic process, either pre-operatively or as apalliative measure). In some embodiments, implants of the presentdisclosure may be used for various endovascular (e.g., neural andperipheral) procedures including procedures for giant cerebral and skullbase aneurysms (ruptured and non-ruptured), head and neck arteriovenousfistulas, dissecting intracranial and extracranial vessels, traumaticand non-traumatic vessel injury or rupture (e.g., pelvic hemorrhages intrauma patients, carotid blow-out in patients with head and neckcancers, hemorrhage induced by a neoplasia, etc.), and devascularizationprior to (or as an alternative to) surgical resection of various organsor tumors.

In certain embodiments, implants of the present disclosure may be usedfor various organs, including for example, the spleen (e.g.,endovascular occlusion as a preoperative intervention or as analternative to surgical resection with indications including traumatichemorrhage, hypersplenism, bleeding secondary to portal hypertension orsplenic vein thrombosis, and various disorders such as thalassemiamajor, thrombocytopenia, idiopathic thrombocytopenic purpura, Gaucherdisease, and Hodgkin disease), the liver (e.g., occlusion of portalveins collaterals as adjunct to a transjugular intrahepaticportosystemic shunt (TIPS), occlusion of the TIPS itself in cases ofencephalopathy, occlusion of intrahepatic arterioportal fistulas), thekidney (e.g., endoluminal ureteral occlusion for intractable lowerurinary tract fistula with urine leakage, or for the treatment ofuretero-arterial fistulae, endovascular occlusion as an alternative tosurgical resection for end-stage renal disease or renovascularhypertension requiring unilateral or bilateral nephrectomy and renaltransplant with native kidneys in situ), and the heart (e.g., occlusionof coronary arteriovenous fistulas, transarterial embolization ofBlalock-Taussig shunts). The application of implants of the presentdisclosure is not limited to applications for human patients, but mayalso include veterinary applications.

According to some embodiments, covers (including patches) disclosedherein and in the above-noted patent applications, including but notlimited to the cover 132, can be attached to a respective implant.Covers disclosed herein may be attached to one or both ends or animplant and/or a middle region of an implant.

According to various embodiments of the subject technology, covers maybe used to occlude, partially or completely, luminal structure in whicha respective implant is deployed. In some embodiments as used herein,occlusion may refer to either partial or complete occlusion. In someembodiments, covers include at least one of a polyurethane, apolyanhidrate, PTFE, ePTFE, silicone, and other suitable materials knownto those of ordinary skill in the art. In some embodiments, covers maybe elastic. In some embodiments, covers may be permeable ornon-permeable.

In some embodiments, an average thickness of a cover is between about0.0005 inches and about 0.006 inches. In some aspects, the averagethickness of a cover may be less than about 0.0005 inches or greaterthan about 0.006 inches. In certain embodiments, an average thickness ofa distal portion of a cover is greater than an average thickness of aproximal portion of a cover. Such a configuration may ensure that moreflow may be reduced at the distal portion of a cover. In someembodiments, the average thickness of the distal portion of a cover isbetween about 0.002 inches and about 0.012 inches. In some embodiments,the average thickness of the distal portion of a cover may be less thanabout 0.002 inches or greater than about 0.012 inches. In someembodiments, the average thickness of the proximal portion of a cover isbetween about 0.0005 inches and about 0.006 inches. In some embodiments,the average thickness of the proximal portion of a cover may be lessthan about 0.0005 inches or greater than about 0.006 inches.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

While certain aspects and embodiments of the inventions have beendescribed, these have been presented by way of example only, and are notintended to limit the scope of the inventions. Indeed, the novel methodsand systems described herein may be embodied in a variety of other formswithout departing from the spirit thereof. The accompanying claims andtheir equivalents are intended to cover such forms or modifications aswould fall within the scope and spirit of the inventions.

What is claimed is:
 1. An expandable device for delivery to a targetlocation in a body vessel, comprising: a frame comprising a proximalloop, a distal loop, and first and second U-shaped link members, thefirst U-shaped link member having a first radius of curvature and thesecond U-shaped link member having a second radius of curvature, whereinthe first and second radii of curvature have a common bend axis, thefirst U-shaped link member having a first proximal end obliquely coupledto the proximal loop at a first proximal location, the second U-shapedlink member having a second proximal end obliquely coupled to theproximal loop at a second proximal location, the second proximallocation being spaced apart from the first proximal location, and asecond end coupled to the distal loop, the first U-shaped link memberfurther having a first distal end obliquely coupled to the distal loopat a first distal location, the second U-shaped link member having asecond distal end obliquely coupled to the distal loop at a seconddistal location, the second distal location being spaced apart from thefirst distal location, the proximal and distal loops being at oppositeends of a longitudinal axis, wherein in an expanded configuration, thefirst and second U-shaped link members (i) are symmetrical with eachother about a first plane passing through the longitudinal axis and (ii)are each symmetrical about a second plane that is oriented perpendicularto the first plane; wherein the frame is expandable from (1) a collapsedconfiguration in which the first and second U-shaped link members aregenerally straight and extend substantially parallel relative to thelongitudinal axis, to (2) an expanded configuration, in moving to which(a) the first and second planes each rotate angularly, relative to thelongitudinal axis, from the collapsed configuration by between about 10degrees and about 170 degrees, and (b) the first and second radii ofcurvature decrease to cause the first and second U-shaped link membersto foreshorten along the longitudinal axis to bias the proximal looptoward the distal loop; and a cover member coupled to the frame.
 2. Thedevice of claim 1, wherein at least one of the proximal or distal loopscomprises an annular shape.
 3. The device of claim 2, wherein, in thecollapsed configuration, the annular shape is positioned in an oblong,deflected state.
 4. The device of claim 2, wherein the annular shape hasan expanded diameter of between about 5 mm and about 15 mm.
 5. Thedevice of claim 1, wherein, in the collapsed configuration, the proximaland distal loops are positioned substantially parallel relative to thelongitudinal axis.
 6. The device of claim 1, wherein, when moving to theexpanded configuration, at least one dimension of the proximal loopexpands within the first plane and at least one dimension of the distalloop expands within the second plane.
 7. The device of claim 1, wherein,in the collapsed configuration, the first and second planes each areoriented at angles of between about 10° and about 50° relative to thelongitudinal axis.
 8. The device of claim 1, wherein, in the expandedconfiguration, the first and second planes each are oriented at anglesof between about 70° and about 110° relative to the longitudinal axis.9. The device of claim 1, wherein the device foreshortens by over 40%when expanding from the collapsed configuration to the expandedconfiguration.
 10. A combination of the expandable device of claim 1 anda delivery system for delivering the expandable device to a targetvessel, the system comprising: a handle portion; a tubular shaftcomprising a proximal end, coupled to the handle portion, and a distalend, comprising a lumen; a delivery component slidably disposed withinthe lumen and configured to advance the expandable device within thelumen for delivery to the target vessel; an actuation component coupledto the handle portion and the delivery component for selectivelyadvancing or retracting the delivery component relative to the shaft;and a release member coupled to the delivery component, the releasemember being movable between an engaged position in which the releasemember engages the proximal and distal loops, and a disengaged position,in which the proximal and distal loops are disengaged from the deliverycomponent.
 11. The combination of claim 10, wherein the release membercomprises an elongate wire extending through a lumen of the deliverycomponent, and the delivery component comprises first and second slots,and wherein in the engaged position, the release member engages theproximal loop through the first slot and the distal loop through thesecond slot, the release member being proximally retractable tosequentially release the distal loop and then the proximal loop from thedelivery component.
 12. An expandable device for delivery to a targetlocation in a body vessel, comprising: a frame comprising a proximalloop, a distal loop, and first and second U-shaped link members, thefirst U-shaped link member having a first radius of curvature and thesecond U-shaped link member having a second radius of curvature, whereinthe first and second radii of curvature have a common bend axis, thefirst U-shaped link member being coupled at its ends to the proximal anddistal loops, the second U-shaped link member being coupled at its endsto the proximal and distal loops, wherein the frame is expandable from(1) a collapsed configuration in which the first and second U-shapedlink members are generally straight and straightened to extendsubstantially parallel relative to a longitudinal axis of the device, to(2) an expanded configuration, in moving to which (a) the proximal anddistal loops each rotate angularly, relative to the longitudinal axis,from the collapsed configuration by between about 10 degrees and about170 degrees, and (b) the first and second radii of curvature decrease tocause the first and second U-shaped link members to foreshorten alongthe longitudinal axis to bias the proximal loop toward the distal loop;and a cover member coupled to the frame.
 13. The device of claim 12,wherein the first U-shaped link member has a first proximal endobliquely coupled to the proximal loop at a first proximal location, thesecond U-shaped link member has a second proximal end obliquely coupledto the proximal loop at a second proximal location, the second proximallocation being spaced apart from the first proximal location, and asecond end coupled to the distal loop, the first U-shaped link memberfurther having a first distal end obliquely coupled to the distal loopat a first distal location, the second U-shaped link member having asecond distal end obliquely coupled to the distal loop at a seconddistal location, the second distal location being spaced apart from thefirst distal location, the proximal and distal loops being at oppositeends of the longitudinal axis, and wherein in an expanded configuration,the first and second U-shaped link members (i) are symmetrical with eachother about a first plane passing through the longitudinal axis and (ii)are each symmetrical about a second plane that is oriented perpendicularto the first plane.
 14. The device of claim 12, wherein at least one ofthe proximal or distal loops comprises an annular shape.
 15. The deviceof claim 14, wherein, in the collapsed configuration, the annular shapeis positioned in an oblong, deflected state.
 16. The device of claim 14,wherein the annular shape has an expanded diameter of between about 5 mmand about 15 mm.
 17. The device of claim 12, wherein, in the collapsedconfiguration, the proximal and distal loops are positionedsubstantially parallel relative to the longitudinal axis.
 18. The deviceof claim 12, wherein, when moving to the expanded configuration, atleast one dimension of the proximal loop expands within the first planeand at least one dimension of the distal loop expands within the secondplane.
 19. The device of claim 12, wherein, in the collapsedconfiguration, the first and second planes each are oriented at anglesof between about 10° and about 50° relative to the longitudinal axis.20. The device of claim 12, wherein, in the expanded configuration, thefirst and second planes each are oriented at angles of between about 70°and about 110° relative to the longitudinal axis.
 21. The device ofclaim 12, wherein the device foreshortens by over 40% when expandingfrom the collapsed configuration to the expanded configuration.